Randomized Controlled Trial of the Comparison of Uniport VATS and Non- Uniport VATS for Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- perioperative blood loss
研究概览
简要总结
Video-assisted thoracoscopic surgery (VATS) has been widely used for non-small cell lung cancer (NSCLC) for nearly two decades. Usually, it was applied through three ports with at least one drainage after surgery, which often lead to acute chest pain. Therefore, fewer, smaller ports, and wider intercostal space for surgery has been required.
Uniport VATS became a feasible option with the development of surgical techniques and instruments, with potentially less postoperative pain and shorter hospital stays. However, there may be some complications, or with a longer time of operation, even more difficult in lymph nodes resection during learning curve.
In our study, a Randomized Controlled Trial was designed to study the operation time, perioperative blood loss, conversion rate, duration of postoperative drainage, length of hospital stay, visual analogue score of postoperative pain, complications, and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with cT1-3N0-1M0 NSCLC; good cardiopulmonary function; prepared to undergo radical resection;
排除标准
- •patients with N3 or M1 NSCLC; poor cardiopulmonary function; not be prepared to undergo radical resection;
结局指标
主要结局
perioperative blood loss
时间窗: 1 day
perioperative blood loss in milliliter
conversion rate
时间窗: 1 day
conversion rate in proportion
length of hospital stay
时间窗: within 5-7 days
length of hospital stay in days
visual analogue score of postoperative pain
时间窗: within 5-7 days
score
operative time
时间窗: 1 day
operative time in minutes
duration of postoperative drainage
时间窗: within 5-7 days
duration of postoperative drainage in days
complications
时间窗: up to 3 months
complications in rate
次要结局
- progression- free survival(up to 5 years)
- overall survival(up to 5 years)